CompletedPhase 1

A Safety Study of TTP4000 in Subjects With Alzheimer's Disease

A Double-blind, Randomized, Placebo-controlled, Phase 1 Study of 2 Escalating, Single Subcutaneous Doses to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of TTP4000 in Subjects With Alzheimer's Disease With Mild Cognitive Impairment

Lead sponsor

vTv Therapeutics

Asset

TTP4000

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Number of participant with adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01548430

Org study IDTTP4000-101

Timeline

Milestones

Study start2011-10 (month precision)

Study first posted2012-03-08estimated

Primary completion2013-02actual (month precision)

Study completion2013-02actual (month precision)

Last update posted2015-02-12estimated

Assets

Drug assets

TTP4000

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Males or females ≥ 50 years of age.

•Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.

•Weight ≥ 50 kg.

•Alzheimer's disease according to the DSM-IV-TR criteria and a score between 20 and 26 on the Mini Mental State Exam.

•Subject must have a medical history for at least 6 months prior to Screening (confirmed by medical records) of a diagnosis of mild Alzheimer's disease

Exclusion criteria

•Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia, including, but not limited to: epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, or head injury with loss of consciousness; DSM-IV-TR criteria for any major psychiatric disorder, including psychosis, major depression, and bipolar disorder.

•Participation and dosing in another clinical trial, involving any marketed or investigational drug, within 30 days before Screening Visit.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Number of participant with adverse events

Time frame:Day 0 to Day 84

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Evaluation of participant plasma TTP4000 concentrations

Time frame:Day 0 to Day 84

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.